<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20210824052280N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-10-17</date_registration>
      <primary_sponsor>Islamic Azad University, Lahijan Branch</primary_sponsor>
      <public_title>The effect of mindfulness on social anxiety, cognitive flexibility and happiness</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of mindfulness-based cognitive-behavioral therapy on social anxiety, cognitive flexibility and happiness in patients with coronary heart disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58578</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method is a simple randomization.  The study has two groups and from the beginning it is agreed that odd numbers will be given to the intervention group and even numbers will be given to the control group.  Then, using random numbers table, the relevant numbers are extracted, each number is written on a card and placed in an envelope, and the envelopes are sealed, and the patient's number is written on each envelope, and the first patient who enters the study  Envelope number 1, patient number 2, envelope number 2 and so on will be given.  Finally, people in two intervention groups (15 people) and control group (15 people) will enter the research.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Coronary heart disease.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group receives cognitive behavioral therapy based on mindfulness. The therapy sessions are as follows: each session lasts for 45 minutes and two sessions per week during four consecutive weeks for a total of eight sessions.  The content of the interventions of each session is as follows: First session: physical examination training and focus on short breathing, reading and meditation reflection, breathing exercise training and doing it, breathing exercise assignment, notes of emotions during exercise.  The second session: practicing thoughts and feelings, people's feedback from the practice, getting to know how to relax.  The third session: conscious movement, meditation and checking the body, discovering the experiences of thoughts and creating images and feelings of the present.  The fourth session: practice of seeing and hearing, meditation and understanding the present moment, practice with sitting meditation.  The fifth session: Reviewing the exercise and examining its effects on the body;  Three-minute breathing exercise.  Sixth session: training in body scanning technique, searching for physical senses (hearing and taste), observing opposite thoughts and alternative views.  Seventh session: Observing the creation of alternative thoughts and views, making a list of energizing (creating a sense of pleasure and mastery) and boring activities.  8th session: body inspection meditation, final meditation, review of the entire course. Intervention 2: Control group: In this study, people in the control group do not receive any intervention and it is created only for the purpose of comparison to determine the effectiveness of the treatment used in the intervention group.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Only general specifications such as information about the main outcome are shared.

When:
The access period begins three months after the publication of the results

To whom:
The use of the results is free for the public, and it is also available to all researchers in the research field under study.

Conditions:
Its use is unrestricted, citing the source.

Where to obtain:
Islamic Azad University Lahijan branch

How to obtain:
Refer to the Open University Branch Library, Theses section

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad.Mahdi Pasandideh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>East Kashef St.</address>
        <city>Lahijan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3951544169</zip>
        <telephone>+98 13 4222 9081</telephone>
        <email>mmpasandideh@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad.Mahdi Pasandideh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>East Kashef St.</address>
        <city>Lahijan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3951544169</zip>
        <telephone>+98 13 4222 9081</telephone>
        <email>mmpasandideh@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The person must have coronary heart disease.
The person must be a resident of Rasht.
The person must be interested in participating in the research.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Inability to read and write.
Taking psychiatric drugs.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I25.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Atherosclerotic heart disease of native coronary artery</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group receives cognitive behavioral therapy based on mindfulness. The therapy sessions are as follows: each session lasts for 45 minutes and two sessions per week during four consecutive weeks for a total of eight sessions.  The content of the interventions of each session is as follows: First session: physical examination training and focus on short breathing, reading and meditation reflection, breathing exercise training and doing it, breathing exercise assignment, notes of emotions during exercise.  The second session: practicing thoughts and feelings, people's feedback from the practice, getting to know how to relax.  The third session: conscious movement, meditation and checking the body, discovering the experiences of thoughts and creating images and feelings of the present.  The fourth session: practice of seeing and hearing, meditation and understanding the present moment, practice with sitting meditation.  The fifth session: Reviewing the exercise and examining its effects on the body;  Three-minute breathing exercise.  Sixth session: training in body scanning technique, searching for physical senses (hearing and taste), observing opposite thoughts and alternative views.  Seventh session: Observing the creation of alternative thoughts and views, making a list of energizing (creating a sense of pleasure and mastery) and boring activities.  8th session: body inspection meditation, final meditation, review of the entire course.</i_keyword>
      <i_keyword>Control group: In this study, people in the control group do not receive any intervention and it is created only for the purpose of comparison to determine the effectiveness of the treatment used in the intervention group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cognitive flexibility score in Dennis and Vanderwaal's cognitive flexibility questionnaire. Timepoint: Before and after the intervention. Method of measurement: Cognitive flexibility questionnaire of Dennis and Vanderwaal.</prim_outcome>
      <prim_outcome>Oxford happiness questionnaire score. Timepoint: Before and after the intervention. Method of measurement: Oxford Happiness Questionnaire.</prim_outcome>
      <prim_outcome>Conover's Social Anxiety Questionnaire. Timepoint: Before and after the intervention. Method of measurement: Conover's Social Anxiety Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Islamic Azad University, Lahijan Branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-09-08</approval_date>
        <contact_name>Ethics Committee of Lahijan Azad University</contact_name>
        <contact_address>Health Building 7, Kamranieh, Talshan Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
